US Regulation of Advertising and Promotion for Drugs and Biologics (2022)

6.0
RAC Credits
Virtual Programs Virtual Programs
Thursday, 11 August 2022 (12:00 PM) - Friday, 12 August 2022 (4:00 PM) Eastern Time (US & Canada)

Examine current guidelines and expectations for advertising and promotion of pharmaceuticals and biologics in the US in this upcoming virtual program. The presenters include FDA presenters, industry leaders, regulatory experts, and legal professionals who will discuss key issues and share their expertise through presentations, discussions, and case studies.

Broken into two half-day sessions, this program will cover the current requirements for advertising and promotion of healthcare products in the US, and how they impact the way you communicate with healthcare professionals, consumers, and managed care audiences.


Pricing Amounts & Deadlines

03 Jun – 13 Jul 2022: Early $495 Member | $580 Nonmember
14 Jul – 11 Aug 2022: Regular $580 Member | $680 Nonmember


Learning Objectives

After this program, participants will be able to:

  • Summarize the current structure and regulatory climate at FDA.
  • Provide a strategic-level overview of the overall regulation of promotional materials.
  • Identify key topics in the advertising and promotion world, including Consistency with Labeling, Direct-to-Consumer (DTC) promotion, Accelerated Approvals, and Payor Communications.
  • Examine the changing ad promo regulatory environment with a focus on user fees and congressional reforms.

Who Should Attend?

Early to mid-level professionals involved in advertising and promotion of drugs for the US market, including:

  • Regulatory affairs professionals
  • Regulatory consultants
  • Compliance specialists
  • Regulatory counsel
  • Commercial representatives (marketing, payor/access)
  • Medical communications professionals
  • Medical affairs
  • Medical Science Liaisons (MSLs)

Agenda

Day 1

(All times are posted in Eastern Standard Time)

 

12:00 pm – 1:00 pm

Strategic Overview of Drug/Biologic Advertising and Promotion Regulation

·        Foundations of Ad-Promo Regulation

o   Overview

o   Role of FDA and OPDP

o   Types of Promotion

·        Role of health care providers and other stakeholders in recognizing and reporting false or misleading promotion

·        Structure and organization of the Office of Prescription Drug Promotion

·        2022 developments

·        Q&A

 

Amy Muhlberg, PhD, Deputy Director, Division of Policy, Research, and Operations (DPPRO), OPDP, FDA

1:00 pm – 1:10 pm

Break

1:10 pm – 2:10 pm

Consistency with Labeling – Analysis of Industry Implementation

·        FDA-Required Labeling

o   Label Negotiations & Impact

o   Cross-Functional Collaboration

·        CFL Guidance Perspective

·        Disclaimers & Context

·        Industry Examples

·        Recent FDA Enforcement

·        Key Takeaways

 

Micheline Awad, MBA, Senior Director Regulatory Affairs, Advertising, Promotion and Labeling, Turning Point Therapeutics, Inc.

2:10 pm – 2:20 pm

Break

2:20 pm – 3:00 pm

Payor Communications

·        Pre-approval Communications

·        Approved Products

·        Unapproved Products

·        Unapproved Uses of Approved Products

·        Q&A

 

Gary C. Messplay, JD, Partner, King & Spalding

3:00 pm – 3:40 pm

PDUFA Changes

·        What the user fee commitment letter(s) mean for AdPromo professionals

·        What the user fee legislation means for AdPromo professionals

·        User fee reauthorization risks

·        Q&A

 

Alexander Gaffney, MS, RAC, Executive Director, Regulatory Policy and Intelligence, POLITICO’s Agency IQ

 

Day 2

12:00 pm – 1:00 pm

Current FDA Environment for Advertising and Promotion

·        Update on OPDP oversight of advertising and promotion, including examples of recent compliance actions and process considerations.

 

Kathleen Klemm, Deputy Director, Division of Advertising and Promotion Review I (DAPRI), OPDP, FDA

1:10pm – 1:20 pm

Break

1:20 pm – 2:20 pm

Accelerated Approvals

·        Review of the subpart H & E pathways

·        Overview of the advertising restrictions unique to this approval pathway

·        Discussion of the recent controversy surrounding accelerated approvals

 

Dale Cooke, JD, MA, President, PhillyCooke Consulting

2:20 pm – 2:30 pm

Break

2:30 pm – 3:30 pm

Direct-to-Consumer (DTC) Pharmaceutical Advertising – New Developments*

·        Influencers

·        Native advertising

·        Social media

·        New platforms

o   Telemedicine

o   Connected TV

·        Q&A

* The presenter is no longer able to present. This will be a recording from 2021. 


* Agenda is subject to change

Download Agenda


Instructors:

Kathleen Klemm

Kathleen Klemm
Deputy Director, Division of Advertising and Promotion Review I (DAPRI), OPDP, FDA

Kathleen (Katie) Klemm is the Deputy Division Director of the Division of Advertising and Promotion Review I in the Office of Prescription Drug Promotion at the Food and Drug Administration. Over the past 13 years, Katie has held the positions of team leader and reviewer in OPDP. She received her Doctor of Pharmacy and Master of Science in Regulatory Science degrees from the University of Maryland School of Pharmacy.

Amy Muhlberg

Amy Muhlberg, PhD
Deputy Director, Division of Policy, Research, and Operations (DPPRO), OPDP, FDA

Amy Muhlberg, PhD, is Deputy Director of the Division of Promotion Policy, Research and Operations in the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) in the Office of Prescription Drug Promotion (OPDP). She joined OPDP in 2021 as a staff fellow leading the development of guidance documents, regulations, and citizen petition responses and coordinating teams of subject matter experts to establish and update policies related to prescription drug promotion. Previously, she held a similar role in FDA’s Office of Policy for Pharmaceutical Quality, working on drug product quality and manufacturing issues across the product lifecycle. She has two decades of FDA policy experience in trade associations, regulated industry and on Capitol Hill. Muhlberg earned her PhD in Biochemistry from The Scripps Research Institute in La Jolla, California and received her undergraduate degree in Biology from McGill University in Montréal, Canada.

Micheline Awad

Micheline Awad, MBA
Senior Director Regulatory Affairs - Advertising, Promotion and Labeling, Turning Point Therapeutics, Inc

Micheline Awad leads the Advertising & Promotion and Labeling functions at Turning Point Therapeutics. She has over 20 years of Biotechnology/Pharmaceutical industry experience, including Regulatory Affairs (RA) strategy, RA - Advertising & Promotion, and recently RA Labeling. Micheline’s Regulatory experience includes Biologic, Drug, and Device, with multiple product/indication launches. She received her M.B.A. from University of Southern California with a focus on Strategy and Marketing, and her B.S. in Biology specializing in Biotechnology from George Mason University.

Dale Cooke

Dale Cooke, JD, MA
President, PhillyCooke Consulting

Dale Cooke, JD, is the president of PhillyCooke Consulting, which helps companies communicate about FDA-regulated products using 21st century tools while remaining compliant with regulations written in the 1960s. Cooke has worked with more than 50 pharmaceutical and medical device clients and more than 20 advertising agencies around the world. His insights have been featured in Politico, The Pink Sheet, Stat News, Law360 and other publications. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), the Alliance for a Stronger FDA, and the Google Health Advisory Board.

Dale holds a B.A. in Philosophy from Southern Methodist University and an M.A. in Philosophy from the University of Arizona, studied Epidemiology and Biostatistics at Drexel University’s School of Public Health, received a graduate certificate in Healthcare Compliance from Seton Hall University’s School of Law and earned his JD at Drexel University’s Kline School of Law.

Alexander Gaffney

Alexander Gaffney, MS, RAC
Executive Director, Life Sciences, POLITICO’s Agency IQ

Alexander Gaffney is the Executive Director of Life Sciences at POLITICO’s AgencyIQ, where he leads the team’s research and analysis of life sciences regulatory issues affecting the Food and Drug Administration. Alexander previously worked at PricewaterhouseCoopers where he led analysis of life sciences regulatory issues for the firm’s prestigious Health Research Institute. Before joining PwC, he was the Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also was Managing Editor of the company’s flagship publication, Regulatory Focus. Alexander has maintained his Regulatory Affairs Certification (RAC) in US regulation since 2013, and also received his master’s degree in regulatory science from the University of Maryland.


Gary C. Messplay

Gary C. Messplay, JD
Partner, King & Spalding

Gary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in the FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies. Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes. Previously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.


Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. Cancellation requests received by Wednesday, 27 July 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 27 July 2022 will be non-refundable, except in cases of documented medical emergencies.   All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.


Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.


Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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